510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JEPClass I

Retainer, Matrix

21 CFR 872.4565 / Dental
FDA source (opens on fda.gov)

JEP is the FDA product code for Retainer, Matrix, a class I device type, regulated under 21 CFR 872.4565. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JEP
Device name
Retainer, Matrix
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code JEP

By decision year
3 clearances under product code JEP with a decision year between 1983 and 2009, 1983 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code JEP by decision year
YearClearances
19831
19931
20091

Applicants with the most clearances

Product code JEP
Applicants holding the most 510(k) clearances under product code JEP
ApplicantClearances
Almore Intl., Inc.1
Garrison Dental Solutions1
Innovative Technology, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 113 companies shown, in name order